Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples

Not Applicable

Recruiting

• Conditions: Substance Use; HIV Infections
• Interventions: Behavioral: Couples Health Project

• Registration Number: NCT06307977
• Lead Sponsor: Hunter College of City University of New York

Brief Summary

This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-13
• Study Start: 2024-05-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2028-01
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 360

Inclusion Criteria

• Have a main partner who is another cisgender male and have been in a relationship for 3 month or longer
• Index participant must be between 18 and 34; Main partner can be any age 18 and older
• One participant must be HIV negative (as confirmed by rapid test)
• One participant must have used at least 1 drug in the past 30 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB, amyl nitrite)
• Index participant must have engaged in TRB in the past 30 days- Defined as CAS with a casual partner, or a serodiscordant or non-monogamous main partner
• Live in the United States
• Speak and read English

Exclusion Criteria

• Any signs of serious mental illness or cognitive deficit
• Current suicidal/homicidal ideations
• History of IPV with their main partner and safety concerns in the current relationship.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Behavioral: Couples Health Project	Couples Health Project	A three-session intervention for couples addressing couples communication skills, substance use, sexual agreements. The intervention also includes couples HIV testing and counseling in the final session.

Primary Outcome Measures

Name	Time	Method
Urine assay for drug use	9 Months	Positive urine screen for drug use assessed bi-annually
Drug use Frequency	9 Months	Number of reported days of illicit drug use (amphetamines, cocaine/crack, GHB, ketamine or ecstasy) reported on quarterly timeline follow-back assessments
CAS with casual partners	9 Months	Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments in the absence of adequate PrEP coverage

Secondary Outcome Measures

Name	Time	Method
Binge Drinking	9 Months	Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview
PrEP Uptake	9 months	self-reported receipt of a PrEP-prescription
Bacterial sexually transmitted infections	9 Months	Any chlamydia or gonorrhea diagnosis

Trial Locations

Locations (3)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Hunter College; 🇺🇸 New York, New York, United States